The present invention is in the field of cleaning surgical instruments, such as flexible and nonflexible endoscopes, surgical lumens, and other medical paraphernalia used in healthcare facilities. This cleaning typically takes place as a preliminary step subsequent to use and soiling of the surgical instruments, and prior to their sterilization.
The physical designs of most models of endoscopes do not make possible the cleaning of every internal surface. It has been a common practice to merely soak used surgical instruments such as biopsy channels or lumens in a detergent bath and scrubbing with a small scrub brush prior to their being sterilized. Since delicate material is often used to make flexible endoscopes, scrub brushes longer than about 2.0 cm have a tendency to damage the lumen. Moreover, small scrub brushes cannot thoroughly scrub the internal surfaces of surgical lumens resulting in contaminants remaining throughout surgical lumens. Pushing a scrub brush through a lumen is also problematic because it may damage the lumen wall.
There is concern about the transmission of diseases that commonly arise in healthcare facilities, and by viruses carried in tissues and blood, such as hepatitis C and HIV, which may be transmitted to other patients or personnel dealing with soiled surgical instruments such as most models of flexible endoscopes. This concern stems from the difficulty in cleaning surgical lumens by a method meticulous enough to scrub a soiled lumen, while at the same time being simple and straightforward enough to be utilized by personnel requiring a minimum amount of training, and using an apparatus which is both inexpensive and reliable. Moreover, it is problematic that surgical lumens and other paraphernalia may be grossly soiled, and therefore require vigorous cleaning throughout the entire length of the surgical lumen, both inside and out. Unfortunately, cleaning agents and brushes are not available which easily accomplish the vigorous cleaning of soiled surgical lumens prior to their microbiological decontamination. This problem is compounded by the fact that cleaning brushes are usually incompatible with flexible surgical lumens. Thus, heretofore, it has not been easy to clean the inside of deep surgical lumens using an elongated brush as described herein.
A number of different methods are known in the art for cleaning surgical instruments and other medical paraphernalia. For example, U.S. Pat. No. 4,867,797 herein incorporated by reference discloses a method for cleaning instruments used for analyzing protein-containing biological liquids which utilizes an enzyme rinse solution, but uses germicides therewith only in low concentrations and only to increase the stability of the enzyme composition by protecting it against microbial deterioration.
U.S. Pat. No. 6,224,544 relates to an endoscope, being insertable in the colon of a patient, in a self-propelled manner, by driving a plurality of endless belts mounted along the outside surface of a flexible section of an insertion tube thereof, and having a cleaning mechanism therein to be easily cleaned after use. The insertion tube, operation unit, and a lower portion of the driving unit casing are cleaned by immersion in a washing vessel filled with a cleaning solution.
U.S. Pat. No. 5,489,531 herein incorporated by reference relates to a two-stage method using the same container for both cleaning and microbiologically decontaminating grossly soiled surgical instruments. A presoak in an enzyme solution is followed by direct addition of a compatible disinfectant and a continued soak to decontaminate surgical instruments and other paraphernalia used in healthcare facilities.
Longitudinal brushes having a twisted wire core are known, such as, for example, mascara brushes used to apply mascara to a user's eyelashes. A typical mascara brush is made of a core formed from a single metallic wire folded in a generally u-shaped configuration to provide a pair of parallel wire segments. Bristles, usually made of strands of nylon, are disposed between a portion of a length of the wire segments. The wire segments are then twisted, or rotated, about each other to form a helical core (also known as a twisted wire core) that holds the filaments substantially at their midpoints so as to clamp them. In this way, a bristle portion or bristle head is formed with radially extending bristles secured in the twisted wire core in a helical or spiral manner. See, for example, U.S. Pat. No. 4,887,622, U.S. Pat. No. 4,733,425, and U.S. Pat. No. 6,481,445 all of which are herein incorporated by reference.
It is problematic that unclean instruments cannot be properly disinfected or sterilized. Moreover, the physical properties of endoscope tubing and the designs of some complex surgical instruments contribute to limiting the effectiveness and reliability of brush devices, detergent systems, and increases the probability that a lumen's internal surfaces may remain contaminated following state-of-the-art cleaning. Accordingly, what is needed is a cleaning brush that provides a simple, cost efficient mechanism for cleaning surgical instruments by providing direct access to the internal surface, as well as cleaning brush kits and systems, which deliver cleaning solution directly to the deep channels of the lumens.
It is also problematic that a brush portion of a cleaning element may not be adequately attached to a handle portion of the cleaning element. This may be particularly problematic in situations, such as those disclosed in U.S. Pat. No. 5,615,439, where the core of the brush portion of the cleaning element may be made from one material (e.g., metal), while the handle portion of the cleaning element is made from some other material (e.g., plastic). In such situations, it is often difficult to achieve an adequate bonding between the brush portion and the handle portion so as to ensure that the parts do not come detached from one another. Such is particularly undesirable when instruments having long, thin lumens are being cleaned, since, if the brush comes detached from the handle while the brush portion is located completely within the lumen, it may be extremely difficult, if not impossible, to remove the brush portion from the lumen without damaging the lumen, thereby causing a waste of time and effort, and possibly rendering the instrument unusable.